Why it was recalled
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Product description
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Lot numbers, UPCs & expiration codes
Lot number: D396436C
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0773-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 19, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 119,539 4-packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eli Lilly & Company
Original FDA data
Every field from FDA enforcement report D-0773-2021, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 88505
- Address
- 839 S Delaware St
- Code information
- Lot number: D396436C
- Postal code
- 46225-1782
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0773-2021
- Classification
- Class II
- Recalling firm
- Eli Lilly & Company
- Product quantity
- 119,539 4-packs
- Termination date
- Aug 7, 2023
- Reason for recall
- Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2021